Back to resultsGold Against Pains From Osteoarthrosis in the Knee
Primary Purpose
Arthritis
Status
Withdrawn
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
gold berlocks
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring arthrosis, gold
Eligibility Criteria
Inclusion Criteria:
Arthrosis in knee joint
Exclusion Criteria:
Need for NSAID
Sites / Locations
- Northern Orthopaedic Division, Klinik Frederikshavn
Outcomes
Primary Outcome Measures
VAS
Secondary Outcome Measures
WOMAC
Full Information
NCT ID
NCT00378339
First Posted
September 19, 2006
Last Updated
March 28, 2014
Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
University of Aarhus, Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00378339
Brief Title
Gold Against Pains From Osteoarthrosis in the Knee
Official Title
Clinical Effects From Implants of Gold Around the Arthrotic Knee Joint. A Randomized, Double Blind, Placebo Controlled Investigation.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn because of lack of approvement from local medical authorities
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
University of Aarhus, Aarhus University Hospital
4. Oversight
5. Study Description
Brief Summary
Gold implantation around arthritic joints is a very popular treatment - but the effect has never been controlled.
Detailed Description
Randomization between
Gold (4 x 3 berlocks, injected under local anesthesia) and
Sham operation - only local anesthesia Functional and pain measures reported through the next 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
arthrosis, gold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
gold berlocks
Primary Outcome Measure Information:
Title
VAS
Secondary Outcome Measure Information:
Title
WOMAC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Arthrosis in knee joint
Exclusion Criteria:
Need for NSAID
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mogens B Laursen, MD, Phd
Organizational Affiliation
Northern Orthopaedic Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Orthopaedic Division, Klinik Frederikshavn
City
Frederikshavn
State/Province
Northern Jutland
Country
Denmark
12. IPD Sharing Statement
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Gold Against Pains From Osteoarthrosis in the Knee
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